- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770196
Intervention Study of Cost-Offset Community Supported Agriculture (CO-CSA)
Farm Fresh Foods for Healthy Kids: Innovative Community Supported Agriculture Cost-Offset Intervention to Prevent Childhood Obesity and Strengthen Local Agricultural Economies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Community Supported Agriculture (CSA) is an innovative approach to increasing consumer access to and consumption of fresh produce, thereby lowering obesity prevalence. However, CSA "share" costs may be a barrier for low-income households with children. This multistate study examines whether subsidizing the cost of CSAs, integrated with tailored education: 1) increases consumption of fruits and vegetables, 2) substitutes fruits and vegetables for more energy-dense foods, and 3) improves overall diet quality and energy balance, thus helping children maintain healthy body weights. It also investigates how cost-offset CSAs ("CO-CSAs") contribute to local agricultural economies. Given the well-documented risk for obesity and limited access to fresh produce among low-income individuals, those households are the target of the intervention in four geographically-diverse states: Vermont, New York, North Carolina and Washington.
FORMATIVE AND LONGITUDINAL RESEARCH: Qualitative and quantitative research is being used to inform implementation of the randomized trial, refine outcome assessment strategies, and provide information needed to design a tailored curriculum to enhance low-income households' knowledge, skills, attitudes, and behaviors related to the use of CSA produce and healthy eating.
In the first year of the study, the investigators conducted interviews and focus groups with stakeholders to gather in-depth data related to the potential of CO-CSA operations to meet the needs and preferences of low-income households and the types of information that would be most valuable to include in the study's curriculum. Key stakeholder groups included adults and children from low-income households, CSA farmers, current full-paying CSA members, and nutrition educators.
The investigators also are conducting a longitudinal quantitative examination of dietary behaviors among current CO-CSA participants in an existing statewide program in Vermont. Using online surveys, the investigators are measuring dietary outcomes quarterly among children, and biannually among adults, from low-income households in the program. Data from Year 1 was used to inform the intervention, while data from subsequent time points will provide an opportunity for analysis of longitudinal patterns.
RANDOMIZED INTERVENTION: In the second phase of the project, the investigators will implement and evaluate a three-year delayed intervention randomized controlled trial of CO-CSA plus skill-based, CSA-tailored education in the four states. The investigators will compare changes in dietary behaviors, reported consumption, energy intake, and weight status parameters between children aged 2-12 in 120 control and 120 intervention households. Two hundred households were enrolled in 2016 and an additional 40 households will be enrolled in 2017. Participant households enrolled in 2016 will receive a CO-CSA share for two seasons and education during their first CO-CSA season (Y1 for intervention households and Y2 for control households). Households enrolled in 2017 will receive a CO-CSA share and education for one season (Y2 for intervention households and Y3 for control households). In addition to outcomes with participants, investigators will conduct economic analysis to evaluate the impact of CO-CSA for farms and communities. While these analyses are not related to the human participants, they are central to the overall project goals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Barker, New York, United States, 14012
- Barker
-
Corning, New York, United States, 14830
- Corning
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Gasport, New York, United States, 14067
- Gasport
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Lockport, New York, United States, 14094
- Lockport
-
Medina, New York, United States, 14103
- Medina
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Newfane, New York, United States, 14108
- Newfane
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Watertown, New York, United States, 13601
- Watertown
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27510; 27514; 27515
- Chapel Hill
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Chapel Hill, North Carolina, United States, 27516; 27517; 27599; 27707
- Chapel Hill
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Pittsboro, North Carolina, United States, 23712
- Pittsboro
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Siler City, North Carolina, United States, 27344
- Siler City
-
-
Vermont
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Bristol, Vermont, United States, 05443; 05472
- Bristol
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Burlington, Vermont, United States, 05401; 05402; 05405
- Burlington
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Burlington, Vermont, United States, 05406; 05408
- Burlington
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Cuttingsville, Vermont, United States, 05738
- Cuttingsville
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Hinesburg, Vermont, United States, 05461; 05462; 05445
- Hinesburg
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Ludlow, Vermont, United States, 05149
- Ludlow
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Rutland, Vermont, United States, 05701; 05702; 05736
- Rutland
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Rutland, Vermont, United States, 05759; 05765
- Rutland
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South Burlington, Vermont, United States, 05407; 05403; 05482
- South Burlington
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Starksboro, Vermont, United States, 05461; 05473
- Starksboro
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Starksboro, Vermont, United States, 05487; 05469; 05443
- Starksboro
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Vergennes, Vermont, United States, 05491
- Vergennes
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Winooski, Vermont, United States, 05404; 05439; 05446; 05449
- Winooski
-
-
Washington
-
La Conner, Washington, United States, 98257
- La Conner
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Mount Vernon, Washington, United States, 98274
- Mount Vernon
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Olympia, Washington, United States, 98502
- Olympia
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Rochester, Washington, United States, 98579
- Rochester
-
Sedro-Woolley, Washington, United States, 98284
- Sedro Woolley
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English-speaking
- Parent or legal guardian of a child in the household between the ages of two and 12 years
- Self-reported income less than 185% of the Federal Poverty Level or report enrollment in SNAP, WIC, or Head Start
- Has access to a computer from which s/he can complete on-line data collection
- Has an active e-mail account or willing to create an e-mail account
- Has not participated in CSA in the past three years
- Willing to purchase the 50% CO-CSA share (can use SNAP benefits if desired and available)
- Willing to attend CSA-tailored education sessions
- Willing to make a firm commitment to three years of participation (2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
- Complete baseline survey
- Pay deposit to farm
Exclusion Criteria:
- Non-English-speaking
- Not the parent or legal guardian of a child in the household between the ages of two and 12 years
- Self-reported income equal to or greater than 185% of the Federal Poverty Level and no report of SNAP, WIC, or Head Start enrollment
- Does not have access to a computer from which s/he can complete on-line data collection
- Does not have an active e-mail account or is not able or willing to create an e-mail account
- Has participated in CSA in the past three years
- Not able or willing to purchase the 50% CO-CSA share
- Not able or willing to attend CSA-tailored education sessions
- Not able or willing to make a firm commitment to three years of participation (for 2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
- Not able or willing to complete baseline survey
- Not able or willing to pay deposit to farm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group One (Two-year Intervention, 2016 Enrollment)
Group one intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year in 2016 and 2017.
During the 2016 season they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year.
In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Experimental: Group Two (Delayed Two-year Intervention, 2016 Enrollment)
Group two intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year in 2017 and 2018.
During the 2017 season they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year.
In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Experimental: Group Three (One-year Intervention, 2017 Enrollment)
Group three intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks in 2017 and will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year.
In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Experimental: Group Four (Delayed One-year Intervention, 2017 Enrollment)
Group four delayed intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks in 2018 and will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year.
In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child's fruit and vegetable intake as measured by short dietary screener
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener.
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Change in child's fruit and vegetable intake as measured by 24-hour dietary recall
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire
Time Frame: Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'
|
Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in child's caloric intake as a percent of estimated energy requirements
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in child's dermal carotenoid levels
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in child's diet quality
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child's BMI percentile
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Height and weight measured by trained research staff
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in child's physical activity
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using survey question on physical activity adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Change in child's sedentary behavior
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using survey questions on TV, video, and computer use adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Changes in parent's ability to select, store, and prepare CSA produce
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
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Data collected using questionnaire module on parent's ability to select, store, and prepare CSA produce
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Changes in parent's ability to prepare foods to minimize added (solid) fat and sugar
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected using questionnaire module on parent's ability to prepare foods to minimize added (solid) fat and sugar
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Changes in parent's ability to substitute fruit and vegetables for energy-dense foods
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected using questionnaire module on parent's ability to substitute fruit and vegetables for energy-dense foods
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Changes in parent's knowledge, attitudes, and beliefs about fruits and vegetables
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected using questionnaire module on parent's knowledge, attitudes, and beliefs about fruits and vegetables
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Changes in availability and accessibility of fruits and vegetables in the home
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Data collected using questionnaire module on the availability and accessibility of fruits and vegetables in the home
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Change in parent's fruit and vegetable intake as measured by short dietary screener
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Change in parent's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Change in parent's dermal carotenoid levels
Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)
|
Baseline to 4 months, 16-month follow-up, and 28-month follow-up
|
Changes in household food security
Time Frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
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Data collected using the USDA 6-item Food Security Survey Module with 30-day reference period
|
Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alice Ammerman, PhD, University of North Carolina, Chapel Hill
- Principal Investigator: Rebecca A. Seguin, PhD, Cornell University
- Principal Investigator: Karla Hanson, PhD, Cornell University
- Principal Investigator: Jane Kolodinsky, PhD, University of Vermont
- Principal Investigator: Marilyn Sitaker, PhD, The Evergreen State College
- Principal Investigator: Stephanie Jilcott-Pitts, PhD, East Carolina University
Publications and helpful links
General Publications
- Seguin-Fowler RA, Hanson KL, Jilcott Pitts SB, Kolodinsky J, Sitaker M, Ammerman AS, Marshall GA, Belarmino EH, Garner JA, Wang W. Community supported agriculture plus nutrition education improves skills, self-efficacy, and eating behaviors among low-income caregivers but not their children: a randomized controlled trial. Int J Behav Nutr Phys Act. 2021 Aug 31;18(1):112. doi: 10.1186/s12966-021-01168-x.
- Lu I, Hanson KL, Jilcott Pitts SB, Kolodinsky J, Ammerman AS, Sitaker M, Wang W, Volpe LC, Belarmino EH, Garner J, Gonsalves L, Seguin RA. Perceptions of nutrition education classes offered in conjunction with a community-supported agriculture intervention among low-income families. Public Health Nutr. 2021 Jul;24(10):3028-3036. doi: 10.1017/S1368980020002773. Epub 2020 Aug 24.
- Seguin RA, Morgan EH, Hanson KL, Ammerman AS, Jilcott Pitts SB, Kolodinsky J, Sitaker M, Becot FA, Connor LM, Garner JA, McGuirt JT. Farm Fresh Foods for Healthy Kids (F3HK): An innovative community supported agriculture intervention to prevent childhood obesity in low-income families and strengthen local agricultural economies. BMC Public Health. 2017 Apr 8;17(1):306. doi: 10.1186/s12889-017-4202-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #: 1501005266
- 2015-68001-23230 (Other Grant/Funding Number: NIFA, USDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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